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Translational Regenerative Medicine - Oncology, CNS and Cardiovascular-Rich Pipeline Features Innovative Stem Cell and Gene Therapy Applications
GBI Research, June 2012, Pages: 95
GBI Research, the leading business intelligence provider, has released its latest research, “Translational Regenerative Medicine - Oncology, CNS and Cardiovascular-Rich Pipeline Features Innovative Stem Cell and Gene Therapy Applications”, which provides insights into the global regenerative medicine therapeutics market. The report provides an in-depth analysis of regenerative medicine and the challenges in translating it into clinical practice, with a focus on stem cell research, gene therapy and tissue engineering.
The report also includes insights into the late-stage R&D pipeline for regenerative medicine and the indications of particular interest in terms of development. Some of the countries focusing on regenerative medicine are looked at for their regulatory and research environment. The report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts.
GBI Research has found that the regenerative medicine market has significant potential for growth, despite the low number of currently approved molecules. Regenerative medicine offers a chance to find curative therapies for disease areas with significant unmet need, including orphan diseases and diseases with a high burden globally, such as cancer and diabetes. In addition, the growth of the elderly population offers a large patient base for regenerative therapies.
However, translating regenerative medicine from basic research and preclinical work to clinical trials in humans and then into medical practice is a challenging process and many applications are as yet unapproved. Some areas, such as wound healing, have seen some success, but gene therapy and many stem cell applications are as yet in their infancy. The direction of the market and the potential for success are examined in this report, along with an analysis of the currently marketed therapies and promising applications being studied in the pipeline.
Scope
- An overview of stem cell therapy, gene therapy and tissue engineering and the current market situation.
- An examination of the current state of research in each of the areas, by therapy area and indication.
- An examination of the late-stage pipeline for stem cell therapy, gene therapy and tissue engineering.
- Key drivers and restraints that have had a significant impact on the market and on each indication.
- Profiles of the regulatory landscape in key countries globally.
- The competitive landscape of the regenerative medicine market, with key companies profiled.
Reasons to buy
- Align your product portfolio to markets with high growth potential.
- Develop market-entry and market expansion strategies by identifying the potential regions and regenerative medicine markets poised for strong growth.
- Create a more tailored national strategy through the understanding of key drivers and barriers of the global regenerative medicine market.
- Develop key strategic initiatives by understanding the key focus areas and top selling therapeutics of leading companies.
- Accelerate and strengthen your market position by identifying key companies for mergers, acquisitions and strategic partnerships.
1.1 List of Tables
1.2 List of Figures
2 Introduction
3 Translational Regenerative Medicine - Market Overview
3.1 Introduction and Background – What is Translational Regenerative Medicine?
3.1.1 Patent Landscape
3.1.2 Regenerative Therapy in Unregulated Settings
3.1.3 Currently Marketed Products – Overview
3.2 Potential Future Impact on the Pharmaceutical Landscape
3.2.1 Overcoming Shortfalls in Pharmaceuticals to Treat some Diseases
3.2.2 New Area for Pharmaceutical Companies to Enter through Licensing Agreements
3.2.3 Highly Priced Therapies
3.2.4 Emerging Economies are Embracing Regenerative Medicine
3.2.5 Academia/Small Biotech Collaborations
4 Regenerative Medicine - Stem Cell Therapy
4.1 Overview
4.2 Different Types of Stem Cells
4.2.1 Embryonic Stem Cells
4.2.2 Mesenchymal Stem Cells
4.2.3 Induced Pluripotent Stem Cells
4.2.4 Very Small Embryonic-Like Stem Cells
4.3 Manufacturing Stem Cells – Challenges of Achieving Large-Scale Consistency
4.4 Market Analysis
4.4.1 Market Prospects
4.4.2 Reimbursement
4.4.3 Service Industries around Stem Cell Therapy
4.5 Discontinued Molecules
4.6 Applications
4.7 Applications: Cardiovascular
4.7.1 Myocardial Infarction
4.7.2 Heart Failure
4.7.3 Congestive Heart Failure
4.7.4 Critical Limb Ischemia
4.8 Applications: Central Nervous System Disorders
4.8.1 Parkinson’s Disease
4.8.2 Multiple Sclerosis
4.8.3 Alzheimer’s Disease
4.8.4 Amyotrophic Lateral Sclerosis
4.8.5 Stroke
4.8.6 Spinal Cord Injury
4.9 Applications: Oncology
4.9.1 Haematological Malignancies
4.10 Applications: Gastrointestinal
4.10.1 Crohn’s Disease and Perianal Fistulas
4.11 Applications: Musculoskeletal
4.11.1 Spinal Fusion
4.12 Late-stage Pipeline Products Overview
4.12.1 Phase III
4.13 Marketed Products
4.13.1 Hearticellgram-AMI
4.13.2 Cartistem
4.13.3 Cupistem
4.14 Drivers/Barriers
4.14.1 Manufacturing Cells Faces Problems in Terms of Achieving Large-Scale Consistency
4.14.2 The Formation of Tumors from Stem Cells is an Ongoing Issue that Must be Overcome
4.14.3 Ethical Issues Delay Research
4.14.4 Stem Cell Tourism Decreases Confidence in Stem Cell Therapy and Overshadows Genuine Research
4.14.5 Many Stem Cell Therapies are Minimally Invasive
5 Regenerative Medicine - Gene Therapy
5.1 Overview
5.2 Gene Therapy Delivery Mechanisms
5.3 Market Analysis
5.4 Applications
5.4.1 Oncology
5.4.2 CNS
5.4.3 Cardiovascular
5.5 Currently Marketed Products
5.5.1 Gendicine
5.5.2 Oncorine
5.5.3 Rexin-G
5.6 Pipeline Prospects
5.6.1 Phase III and NDA Filing
5.7 Setbacks with Late-Stage Pipeline Products
5.7.1 Glybera
5.7.2 Cerepro
5.8 Drivers/Barriers
5.8.1 High Profile Deaths Reduce Confidence in the Field among Companies, Regulatory Authorities and Patients
5.8.2 Safety Issues with Use of Viral Vectors
5.8.3 Ensuring a Long-term Therapeutic Benefit from Gene Therapy is Difficult
5.8.4 Scientific Hurdles to Overcome are Still Numerous
5.8.5 Approvals in China have been Criticized as Being too Hasty
6 Regenerative Medicine - Tissue Engineering
6.1 Overview
6.2 Types of Scaffold
6.3 Market Analysis
6.4 Applications
6.4.1 Organ Transplantation
6.4.2 Wound Management
6.4.3 Orthopedics
6.4.4 Cardiovascular
6.5 Marketed Products
6.5.1 Apligraf
6.6 Drivers/Barriers
6.6.1 Drivers
6.6.2 Barriers
7 Translational Regenerative Medicine to 2018 - Geographical Landscape
7.1 The US
7.1.1 Regulatory Overview
7.1.2 Current Legislation and Regulatory Framework
7.1.3 Probable Future Developments
7.2 The EU
7.2.1 The UK
7.2.2 France
7.2.3 Germany
7.2.4 Italy
7.3 Japan
7.4 Other Economies
7.4.1 China
7.4.2 South Korea
7.4.3 Israel
7.4.4 Singapore
7.4.5 Australia
7.4.6 Canada
8 Translational Regenerative Medicine to 2018: Opportunities and Challenges
8.1 Opportunities
8.1.1 An Increasingly Elderly Population Increases the Number of Patients that Could Benefit from Regenerative Therapies
8.1.2 Regenerative Medicine Targets Diseases with High Unmet Need
8.1.3 There are Many Organizations Providing Funding, Including Private, Government and Public Bodies
8.1.4 High Treatment Costs
8.1.5 Many Countries have Permissive Laws Designed to Encourage Regenerative Medicine Innovation
8.2 Challenges
8.2.1 High Costs will Cause Problems with Reimbursement
8.2.2 There are High Risks to Investment
8.2.3 “One to Many” or “One to One” Approach to Regenerative Therapy?
8.2.4 European Court of Justice Ruled that Patents Cannot Apply to the Products of Research Involving the Destruction of Human Embryos
8.2.5 The Regulatory Landscape is Young and Requires Further Formalization
8.2.6 There are Still Many Scientific and Technical Hurdles to Overcome
8.2.7 Unregulated Use of Regenerative Medicine Harms the Research Landscape
9 Translational Regenerative Medicine to 2018 - Competitive Landscape
9.1 Companies Overview
9.2 Company Profiles
9.2.1 Ark Therapeutics
9.2.2 Organogenesis
9.2.3 Tengion
9.2.4 Advanced BioHealing
9.2.5 AMT
9.2.6 GSK
9.2.7 Epeius
9.2.8 Osiris
9.2.9 Cardio3
9.2.10 CorMatrix Cardiovascular
9.2.11 Aastrom
9.2.12 BioHeart
9.2.13 Cytori
9.2.14 Mesoblast
9.2.15 Geron
9.2.16 ReNeuron
10 Appendix
10.1 Market Definitions
10.2 Abbreviations
10.3 Sources
10.4 Research Methodology
10.4.1 Coverage
10.4.2 Secondary Research
10.4.3 Primary Research
10.5 Therapeutic Landscape
10.5.1 Epidemiology-based Forecasting
10.5.2 Market Size by Geography
10.6 Geographical Landscape
10.7 Pipeline Analysis
10.8 Competitive Landscape
10.8.1 Expert Panel Validation
10.9 Contact Us
10.10 Disclaimer
10.11 Disclaimer
1.1 List of Tables
Table 1: Cystic Fibrosis Therapeutics Market, Global, Phase III Pipeline, 2011
Table 2: Organogenesis Products, 2011
1.2 List of Figures
Figure 1: Regenerative Medicine, Global, Main Branches, 2009
Figure 2: Stem Cell Therapy, Global, Types of Stem Cell, 2012
Figure 3: Stem Cell Therapy, Global, Historic Revenue, $m, 2005–2010
Figure 4: Stem Cell Therapy, Global, Pipeline by Therapy Area, 2011
Figure 5: Stem Cell Therapy, Global, Cardiovascular Pipeline by Phase, 2012
Figure 6: Stem Cell Therapy, Global, CNS Pipeline by Phase, 2012
Figure 7: Stem Cell Therapy, Global, Oncology Pipeline by Phase, 2012
Figure 8: Stem Cell Therapy, Global, Gastrointestinal Pipeline by Phase, 2012
Figure 9: Stem Cell Therapy, Global, Musculoskeletal Pipeline by Phase, 2012
Figure 10: Stem Cell Therapy, Global, Drivers and Barriers, 2012
Figure 11: Gene Therapy, Delivery Mechanisms Overview, 2012
Figure 12: Gene Therapy, Global, Pipeline by Therapy Area, 2012
Figure 13: Gene Therapy, Global, Oncology Pipeline by Phase, 2012
Figure 14: Gene Therapy, Global, CNS Pipeline by Phase, 2012
Figure 15: Gene Therapy, Global, Cardiovascular Pipeline by Phase, 2012
Figure 16: Gene Therapy, Global, Drivers and Barriers, 2012
Figure 17: Tissue Engineering, Scaffold Types, 2012
Figure 18: Tissue Engineering, Global, Drivers and Barriers, 2012
Figure 19: Translational Regenerative Medicine, Global, Drivers and Barriers, 2012
Figure 20: Ark Therapeutics, SWOT, 2011
Figure 21: Organogenesis, SWOT, 2011
Figure 22: Tengion, SWOT, 2011
Figure 23: Advanced Biohealing, SWOT, 2011
Figure 24: AMT, SWOT, 2011
Figure 25: GBI Research Market Forecasting Model
More Guidelines Needed to Grow Regenerative Medicine Market, Report Finds
Standardized research guidelines are needed to control and encourage the development of gene therapy and stem cell treatments, according to a new report by healthcare experts GBI Research.
The new report* shows how regenerative medicine is seen as an area with high future potential, as countries need ways to cope with the burden of an aging population.
The stem cell market alone is predicted to grow to around $5.1 billion by 2014, while gene therapy has also shown promise despite poor understanding of some areas of regenerative medicine and a lack of major approvals (the only approvals to date being made in Asia).
Up until now, securing research within clinics has been difficult, with a high number of failures and discontinuations throughout all phases of clinical study. Stem cell therapy uses bone marrow transplants as an established treatment method, but the development of the therapy into further applications and has not yet become common practice.
Similarly, tissue engineering has been successful in the areas of skin and bone grafts, but translation into more complex therapies has been an issue for researchers. Although scientific possibilities are ever-increasing, the true potential of regenerative medicine has yet to be demonstrated fully.
A desire to discover new and innovative technologies has encouraged governments in the UK and Singapore to focus directly on regenerative medicine as a future potential economy booster. They have provided funding and incentives for companies to conduct their research in the country, along with the creation of hubs of knowledge and permissive regulatory environments to encourage research. Funding for industry and research groups is a vital part of furthering regenerative medicine, especially in taking therapies through clinical trials and on to commercialization. As more regions find a desire to attract industry and expertise, more focus is likely to be given to regenerative medicine.
However, uncertainties over legislation and funding from government bodies, especially in regard to ethically controversial therapies such as human embryonic stem cell research, are still deterring investors. President Obama overturned a ruling on a ban on NIH (US National Institutes of Health) funding for human embryonic stem cell research, but a newly elected party may scrap this valuable route of funding.
Regulatory pathways for the new and emerging field of regenerative medicine can create problems. Requirements for clinical trial design, required endpoints and approval legislation are still developing and often differ between countries, creating problems for companies looking to enter markets internationally.
Organizations such as the International Society for Stem Cell Research (ISSCR) publish recommended guidelines on working with stem cells, but these are not binding. Governments must therefore come together to determine a standardized framework for innovative medical research, in order that positive results and long-term follow-up data can be produced to solidify the reputation and investment potential of the regenerative medicine market.
- Ark Therapeutics
- Organogenesis
- Tengion
- Advanced BioHealing
- AMT
- GSK
- Epeius
- Osiris
- Cardio3
- CorMatrix Cardiovascular
- Aastrom
- BioHeart
- Cytori
- Mesoblast
- Geron
- ReNeuron
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